Cardiovascular Systems launches combined Diamondback 360, DES trial

Cardiovascular Systems (NSDQ:CSII) said today it enrolled the 1st patient in the Eclipse clinical trial of its Diamondback 360 coronary orbital atherectomy system.

The St. Paul, Minn.-based company is looking to enroll 2,000 patients in the trial which aims to explore the use of the Diamondback 360 device for treating patients with severely calcified coronary lesions prior to drug-eluting stent placement.

A control group will consist of patients treated with conventional angioplasty, including specialty balloons, prior to DES placement, the comapny said.

The trial’s primary endpoint will be post-procedural minimal cross-sectional area as well as target vessel failure at 1 year, Cardiovascular Systems said.

“Many of us feel that coronary atherectomy is underutilized, particularly given the increasing complexity of lesions and patients seen in current-day interventional practice. Eclipse is the largest randomized clinical trial to date expressly designed to assess the utility of adjunctive coronary atherectomy for calcific CAD,” principal investigators Dr. Ajay Kirtane of the New York-Presbyterian/Columbia University Irving Medical Center said in a prepared statement.

“Coronary calcification has been shown to increase procedural difficulty and adverse events following conventional percutaneous coronary intervention. The use of orbital atherectomy has the ability to significantly modify lesion morphology, enabling successful stent delivery to help optimize stent expansion and apposition. This supports why we are randomizing to conventional angioplasty, toward the goal of ultimately improving PCI outcomes. The value of this trial is that it will inform physicians regarding the most effective treatment protocols and strategies for treating patients with calcific CAD,” co-principal investigator Dr. Philippe Généreux of New Jersey’s Morristown Medical Center

“Our commitment to clinical rigor continues to be a cornerstone in advancing our leadership in atherectomy. The Eclipse trial is another important scientific step in demonstrating that the Diamondback 360 Coronary OAS will broaden physicians’ ability to safely and effectively treat more challenging CAD patients,” CEO Scott Ward said in a press release.

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